Description

Ozagrel Impurity 37 CAS NO 530145-11-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antiplatelet drug Ozagrel during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Ozagrel Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurity levels throughout the drug manufacturing process.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical QC laboratories to ensure drug substance and product meet stringent purity specifications.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (e.g., heat, humidity, light) to establish drug shelf life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive understanding and control of the drug's impurity profile.
• Research & Development: Facilitates chemical and metabolic studies to understand the properties and behavior of this impurity, supporting process optimization and safety assessments.

Basic Information

Product Name	Ozagrel Impurity 37
CAS No.	530145-11-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ozagrel Related Compound 37; Ozagrel EP Impurity I; Ozagrel Process Impurity; (E)-3-[4-(1H-Imidazol-1-ylmethyl)phenyl]-2-propenoic acid (proposed); Ozagrel Metabolite Analog; Impurity of Ozagrel Sodium; Antiplatelet Agent Impurity
EINECS	Contact for details

Quality Control

Every batch of Ozagrel Impurity 37 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards (e.g., USP, EP, ICH guidelines) for reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity data is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity. Avoid repeated or prolonged exposure to air.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.